Dive Brief:
- Allergan plc has secured an additional approval for its fixed-dose antibiotic Avycaz (ceftazidime/avibactam) for hospital-acquired (HABP) and ventilator-associated (VABP) bacterial pneumonia caused by gram-negative microorganisms.
- The Food and Drug Administration OK'd the drug based on Phase 3 safety and efficacy data from the REPROVE study, which showed the antibiotic didn't expose patients to any greater risk of death over a 28-day period compared to meropenem. Avycaz received a Qualified Infectious Disease Product designation from the FDA, granting its supplemental New Drug Application priority review.
- Avycaz was already indicated as a monotherapy for urinary tract infections and as a combination therapy with metronidazole for complicated intra-abdominal infections. Allergan holds commercialization rights for its product in North American, while Pfizer Inc. markets it in the rest of the world under the brand name Zavicefta.
Dive Insight:
The fight against drug resistant bacteria goes on, and gram-negative bugs are some of the hardest to fight. They are behind more than 40,000 resistant infections in the U.S. each year, according to Allergan's Chief R&D Officer David Nicholson.
HABP and VABP are linked with larger healthcare costs, longer stays in hospital and increased mortality rates. The FDA notes that patients staying in a hospital for more than two days are at risk of colonization from common bacteria, such as P. aeruginosa and Staphylococcus aureus, that can give rise to those illnesses.
"Clinical efficacy along with patient safety are critical priorities to clinicians managing serious gram-negative bacterial infections. We are thrilled to have a new option available to treat HABP/VABP, some of the most challenging gram-negative infections in the hospital setting," said Jose Vazquez, division chief and professor of medicine infectious diseases at the Medical College of Georgia/Augusta University.
Sensing the need for more antibiotics, more than 70 drugmakers — including heavyweights like Pfizer and Johnson & Johnson — formed a collaboration in early 2016 aimed at urging governments to better incentivize development of such treatments. Yet while some incentives have materialized, the challenges are still daunting.
Finding new approaches to antimicrobials is difficult, and it's hard to get a return on investment as existing drugs are low-cost. Perhaps most challenging of all, new antibiotics that are successful against resistant organisms are likely to be kept on the shelf as drugs of last resort, to reduce the risk of further resistance developing.
As with cancer drugs, combination approaches may be key. Avibactam is a beta-lactamase inhibitor that can restore antibacterial activity to cephalosporins by stopping the breakdown of the antibiotic by resistant bacteria. Allergan is also working on a combination of aztreonam and avibactam for gram-negative infections.